According to the Summary document, the deadline for receipt of public comments on proposals submitted at this meeting is November 16, 2012. If there is any change to this date, I will update.

Comments on proposals presented at the ICD-9-CM Coordination and Maintenance Committee meeting should be sent to the following email address: nchsicd9CM@cdc.gov. See Page One of the Summary document for important information on submission of public comment.

Extract, Summary document

Lori Chapo-Kroger, representing the Coalition 4 ME/CFS, expressed that many nations, and the World Health Organization, put CFS at G93 in ICD-10, and that this would include everyone but the U.S.

Mary Dimmock, representing the Coalition 4 ME/CFS, questioned why the change must wait until after 2014 when they feel that this is an error in the classification right now (and has been since 2001).

Dr. Kogelnik indicated that the term myalgic encephalomyelitis is used in Europe while the U.S. continues to use the term chronic fatigue syndrome, and that the Coalition 4 ME/CFS considers these two conditions (CFS and ME) to be the same. That is why they want both terms included in the same code.

Nelly Leon-Chisen, AHA, noted support for a need for a code for chronic fatigue syndrome distinct from chronic fatigue, unspecified. She indicated also that with the cause being unknown it is better that the classification not be locked into placing CFS as a viral code. Also, if there is no consensus for ME and CFS being the same then it makes sense to keep them as two separate codes. If research later develops that says they are the same then the data can be aggregated together. However, if the research does not show this, then you don’t have them lumped into one code that does not allow you to separate out one from the other.

Sue Bowman, AHIMA, questioned counting all CFS as following a virus infection. She expressed a need for clinical consensus on this condition. Also, she stated that she did not see a rationale for an early change (before 2014).

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Note: Dx Revision Watch has no connection with the Coalition 4 ME/CFS or with the development of any proposals submitted by this organization. The views and opinions expressed in Coalition 4 ME/CFS submissions to ICD-9-CM Coordination and Maintenance Committee meetings represent the views of the Coalition 4 ME/CFS and its representatives and not the views of Dx Revision Watch.

All enquiries about proposals submitted to CMS/CDC on behalf of the Coalition 4 ME/CFS should be addressed directly to the Coalition 4 ME/CFS.

Note also that the proposal from the Coalition 4 ME/CFS (Option 1) and the alternative proposal presented by CMS/CDC (Option 2) at the September meeting are set out in accordance with the requirements of the ICD-9-CM Coordination and Maintenance Committee for the submission of proposals.

Note: I have no connection with the Coalition 4 ME/CFS or with the development of any proposals submitted by this organization. All enquiries about the proposal submitted to CMS/CDC on behalf of the Coalition 4 ME/CFS should be addressed directly to the Coalition 4 ME/CFS.

Note also that the proposal from the Coalition 4 ME/CFS and the alternative proposal from CMS/CDC are set out in accordance with the requirements of the ICD-9-CM C & M Committee for the submission of proposals.

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Coding of CFS in the forthcoming US specific ICD-10-CM

At the ICD-9-CM Coordination and Maintenance Committee’s September 14, 2011 meeting, a presentation had been made on behalf of the Coalition 4 ME/CFS in relation to the formal submission of a proposal.

The proposal requested that consideration be given to moving the classification of Chronic fatigue syndrome from its current proposed location within the ICD-10-CM R code chapter (Chapter 18: Symptoms and signs) to the G code chapter (Chapter 6: Diseases of the nervous system).

This would bring the chapter location of Chronic fatigue syndrome in ICD-10-CM in line with the international version of ICD-10, the Canadian ICD-10-CA and proposals for the forthcoming ICD-11.

No NCHS decision reached in response to the September 2011 proposals and the public comments received in respect of these proposals was conveyed following closure of the public comment period, last November.

However, further discussion of Chronic fatigue syndrome and two additional proposals are tabled on the agenda for discussion at the September 19, meeting, tomorrow.

I am appending the relevant extract from the Diagnosis Agenda and Proposals document which was published on the CDC website overnight. An official audio and a Summary of the meeting should be available in due course on the CDC website. I will update with these when available.

A proposal, submitted by the Coalition 4 ME/CFS, to modify codes for chronic fatigue syndrome (CFS) was presented and discussed at the September 2011 ICD Coordination and Maintenance Committee meeting. The National Center for Health Statistics also presented an alternative proposal, Option 2. There were many comments from the audience, and there was general support for the NCHS-proposed Option 2, moving CFS from Chapter 18, Symptoms, signs and abnormal clinical findings, not elsewhere classified, to Chapter 6, Diseases of the Nervous System but retaining separate codes for CFS and myalgic encephalomyelitis (ME). The rationale for retaining separate codes included agreement on the importance of being able to extract data on the two conditions separately or combine, as needed. It was also noted that term ME is not seen in medical record documentation. Written comments received on this issue were inconclusive. There was not agreement that the two conditions are the same. While some comments were from private citizens, others were from advocacy organizations and associations that represent health care providers and other large constituencies that use the classification. The public comment period following the meeting is not meant as a poll or survey. Analysis of public comment focused on the substance of the comments; whether there was a clear scientific consensus regarding the etiology and manifestations of the condition; and an understanding of the classification, its structure and conventions, and its uses by the health care industry.

As noted in the information from the September 2011 presentation, the cause or causes of CFS remain unknown, despite a vigorous search. While a single cause for CFS may yet be identified, another possibility is that CFS represents a spectrum of illnesses resulting from multiple possible pathways. Conditions that have been proposed to trigger the development of CFS include infections, trauma, immune dysfunction, stress, and exposure to toxins. Research in this area is ongoing.

There are several case definitions currently in use, some separating CFS from ME, and others merging the two conditions. The most widely used are the 1994 case definition (http://www.cdc.gov/cfs/case-definition/index.html ), the Canadian and the Oxford definitions. A new case definition for ME was published in the 2011 international consensus criteria that emphasized recent research and clinical experience that strongly point to widespread inflammation and multisystem symptoms and neuropathology. This new definition, which considers ME and CFS as synonymous terms, however, has not been widely vetted by the health care community at large. While there is no consensus on one case definition, there is consensus that this is a serious and complex syndrome, and it is likely that there are multiple subgroups. It has been noted that some providers use the terms interchangeably while others consider one condition a subgroup of the other. There is also some overlap with fibromyalgia and CFS/ME could be considered one of the multiple chronic overlapping pain conditions.

The Coalition 4 ME/CFS has stated that they do not support Option 2 proposed in September 2011 and have submitted a revised proposal. A revised Option 2 is also being proposed, consistent with comments received supporting Option 2 as noted above. The Coalition is also requesting that their proposal be considered for implementation prior to October 1, 2014 even though the condition is not a new disease and therefore does not meet the criteria for implementation during the partial freeze.

Based on the above, the following proposals for consideration are:

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For comparison, the proposal that had been presented by CDC at the September 2011 meeting in counterpoint to an earlier proposal presented by the Coalition 4 ME/CFS at that same meeting was this:

• Instead of Title term G93.3 Postviral and other chronic fatigue syndromes (CDC Option 2, September 2011)

I have received the recommendations developed by the Chronic Fatigue Syndrome Advisory Committee (CFSAC) during its November 8-9, 2011, meeting. The advice and counsel provided by CFSAC serves as a valuable resource in the Department of Health and Human Services’ (HHS) efforts to properly address the issues and concerns pertaining to chronic fatigue syndrome.

Since the meeting the Department has carefully considered your recommendations. Dr. Nancy Lee, the Designated Federal Officer for CFSAC, has worked collaboratively with the ex officio representatives to the committee to provide responses to the recommendations developed at the meeting. The enclosed document contains information about activities currently undertaken by HHS to work with public health experts and members of the chronic fatigue syndrome community to increase knowledge and provide a better understanding of this debilitating health condition.

I have shared the committee’s recommendations with Secretary Kathleen Sebelius.

The Department is committed to addressing this condition. I commend you and your committee members for the important work you do.

Recommendation 1: This recommendation addresses the process by which CFSAC transmits recommendations to the Secretary and the Secretary communicates back to CFSAC whether or not a recommendation was acted upon. CFSAC recommends that this process be transparent and clearly articulated to include regular feedback on the status of the Committee’s recommendations. This communication could originate directly from the Office of the Secretary or be transmitted via the relevant agency or agencies.

Procedures are in place to ensure that recommendations made by federal advisory committees are properly handled. The CFSAC charter stipulates that the Committee provides advice and recommendations to the Secretary, through the Assistant Secretary for Health (ASH). Initially, the CFSAC recommendations are sent to the ASH for review. After reviewing the recommendations, the ASH forwards them to appropriate officials within the Office of the Secretary and the Operating and/or Staff Divisions that may be impacted by the Committee’s recommendations. A letter is sent to acknowledge receipt of the recommendations. A response may be prepared to accompany the letter which describes any actions that the Department may take in response to the recommendations made by the Committee. All pertinent information about the recommendations is provided to the designated Federal officer (DFO). The DFO then provides the information to the Chair and the Committee.

Recommendation 2: CFSAC recommends to the Secretary that the NIH or other appropriate agency issue a Request for Application (RFA) for clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS).

The National Institutes of Health (NIH) funds research on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS); investigators are encouraged to submit proposals for ME/CFS research, including clinical trials, through two funding announcements that are currently open for submission of applications. The next deadline for receipt of applications is October 24, 2012. In fiscal year 2011, NIH funded two applications for clinical trials on ME/CFS. NIH has received few applications proposing ME/CFS research, and even fewer applications proposing ME/CFS clinical trials. It is unclear whether the paucity of ME/CFS clinical trial applications reflects the current status of the field or an acknowledgement that clinical trials are difficult to design for a complex and multi-faceted illness. Clinical trials are challenging to design and conduct for all diseases, with basic requirements of a well-defined patient population, valid measurement instruments, appropriate safeguards for subjects, and generalizability of the clinical trial outcomes to the larger affected patient population. NIH is taking action to stimulate ME/CFS research across NIH through the regular monthly meetings of the Trans-NIH ME/CFS Working Group (WG). The WG discusses the current status of ongoing research on ME/CFS and proposes methods to increase the number and quality of research applications submitted to NIH ranging from preclinical research to clinical trials. In addition, the WG is focusing on the recommendations from the April 2011 State of the Knowledge Workshop on ME/CFS to develop priorities. The outcome from these planning sessions will suggest a range of activities and research.

Recommendation 3: CFSAC would like to encourage and support the creation of the DHHS Interagency Working Group on Chronic Fatigue Syndrome and ask this group to work together to pool resources that would put into place the “Centers of Excellence” concept that has been recommended repeatedly by this advisory committee. Specifically, CFSAC encourages utilizing HHS agency programs and demonstration projects, available through the various agencies, to develop and coordinate an effort supporting innovative platforms that facilitate evaluation and treatment, research, and public and provider education. These could take the form of appropriately staffed physical locations, or be virtual networks comprising groups of qualified individuals who interact through a variety of electronic media. Outreach and availability to underserved populations, including people who do not have access to expert care, should be a priority in this effort.

HHS leadership has identified the need for a Department-wide plan to address ME/CFS. The Department established the HHS Ad Hoc Workgroup on ME/CFS to develop a plan and to identify opportunities for interagency collaboration. The HHS ME/CFS plan will highlight recently initiated programs and future agency-specific and cross-agency activities. In developing the report, the Ad Hoc Workgroup will consider recommendations made by CFSAC. After completion, the ME/CFS plan will be posted on the CFSAC website. The DFO, Nancy C. Lee, M.D. is responsible for providing leadership and coordination for development of the HHS ME/CFS report.

c) CFSAC continues to recommend that ME/CFS should be classified in ICD-IO-CM in Chapter 6 under Diseases of the Nervous System at G93.3 in line with ICD-IO, the World Health Organization, and ICD-I-CA [sic], the Canadian Clinical Modification and in accordance with CFSAC’s recommendations of August 2005 and May 2011. CFSAC rejects CDC’s National Center for Health Statistics (NCHS) Option 2 and recommends that ME/CFS remain in the same code and the same subcode as myalgic encephalomyelitis because CFS includes both viral and non-viral triggers.

d) CFSAC recommends that an “excludes one”* be added to G93.3 for chronic fatigue, R53.82, and neurasthenia, F48.8. CFSAC recommends that these changes be made in ICD-10-CM prior to its rollout in 2013.**

[*Ed: Should read “Excludes 1”. For definitions for “Excludes1″ and “Excludes2″ see Post #118]

[**Ed: On August 3, HHS announced Final Rule to delay compliance date for ICD-10-CM/PCS to October 1, 2014.]

Development and implementation of the guidelines for the lCD-10 fall within HHS under the purview of the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services. Use of the revised codes will provide robust and specific data that will improve patient care and enable the international comparability of health care data. On February 16, 2012, the Department issued a press release announcing that HHS would initiate a process to postpone the date that certain health care entities must comply with the ICD-10.

A proposal to change the classification of ME/CFS in ICD-10-CM was presented at the September 2011 Coordination and Maintenance (C & M) Committee/CDC/NCHS; a subsequent proposal was received on January 12, 2012 and will be presented at the September 19, 2012 C & M meeting for additional discussion.

Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 240 people.

Security Considerations: Due to increased security requirements CMS has instituted stringent procedures for entrance into the building by non-government employees. Attendees will need to present valid government-issued picture identification, and sign-in at the security desk upon entering the building. Attendees who wish to attend a specific ICD-9-CM C&M meeting on September 19, 2012, must submit their name and organization by September 10, 2012, for inclusion on the visitor list. This visitor list will be maintained at the front desk of the CMS building and used by the guards to admit visitors to the meeting.

Participants who attended previous ICD-9-CM C&M meetings will no longer be automatically added to the visitor list. You must request inclusion of your name prior to each meeting you attend.

The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention, and the Agency for Toxic Substances and Disease Registry.

Dated: August 9, 2012.

Catherine Ramadei,

Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.

[FR Doc. 2012-20019 Filed 8-14-12; 8:45 am]

BILLING CODE 4160-18-P

(c) 2012 US Federal Register

+++Related posts:

At the ICD-9-CM Coordination and Maintenance Committee’s September 14, 2011 meeting, a presentation was made on behalf of the Coalition 4 ME/CFS in relation to the formal submission of a proposal that consideration be given to moving the classification of Chronic fatigue syndrome from its current proposed location within the ICD-10-CM R code chapter (Chapter 18: Symptoms and signs) to the G code chapter (Chapter 6: Diseases of the nervous system).

This would bring chapter location and parent class coding of Chronic fatigue syndrome in line with the international version of ICD-10, published in 1990, the Canadian ICD-10-CA and proposals for the forthcoming ICD-11.

No decision in response to the proposal, meeting discussions and public comment received has been conveyed following closure of the public comment period. Further discussion of Chronic fatigue syndrome has been tabled on the tentative agenda for the September 19, 2012 meeting.

I will post Summary documents and other relevant meeting materials as these become available. There are three posts on Dx Revision Watch that relate to and report on the presentation at the September 14, 2011 meeting:

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services via the Assistant Secretary for Health of the U.S. Department of Health and Human Services on issues related to chronic fatigue syndrome (CFS). These include:

• factors affecting access and care for persons with CFS;• the science and definition of CFS; and• broader public health, clinical, research and educational issues related to CFS.

Administrative and management support for CFSAC activities is provided by the Office of the Assistant Secretary for Health (OASH). However, staffing will continue to be provided primarily from the Office on Women’s Health, which is part of OASH.

The Chronic Fatigue Syndrome Advisory Committee (CFSAC), 2012 spring meeting will be held on Wednesday, June 13, 2012 from 9:00 a.m. until 5:00 p.m. EST and Thursday, June 14, 2012 from 9:00 a.m. until 5:00 p.m. EST.

The meeting will be held at the U.S. Department of Health and Human Services, Hubert Humphrey Building, 200 Independence Avenue, S.W., Room 800, Washington, D.C. 20201. For directions please visithttp://www.hhs.gov/about/hhhmap.html .

The meeting will be webcast live and available by audio (listening-only). Additional information and the CFSAC agenda will be posted to the CFSAC website by June 4, 2012.

Update: May 24, 2012

Above notice now reads:

The meeting will provide a live video stream and be available by audio (listening only). Additional information and the CFSAC agenda will be posted to the CFSAC website by June 4, 2012. Instructions for public testimony will be provided at a later date in a Federal Register Notice. We are not accepting requests or testimony at this time.

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services via the Assistant Secretary for Health of the U.S. Department of Health and Human Services on issues related to chronic fatigue syndrome (CFS). These include:

• factors affecting access and care for persons with CFS;• the science and definition of CFS; and• broader public health, clinical, research and educational issues related to CFS.

Administrative and management support for CFSAC activities is provided by the Office of the Assistant Secretary for Health (OASH). However, staffing will continue to be provided primarily from the Office on Women’s Health, which is part of OASH.

The Agenda item with the most relevance for this site was the issue of the current proposals for chapter placement and coding for Chronic fatigue syndrome in the forthcoming US specific ICD-10-CM, the proposals presented for consideration at the September meeting of the ICD-9-CM Coordination and Maintenance Committee on behalf of the Coalition for ME/CFS, and an alternative proposal presented by NCHS.

See this Dx Revision Watch post (Post #118, December 27, 2011) for a report on the Fall 2012 Meeting presentation by Donna Pickett (NCHS) and discussions of proposals for ICD-10-CM:

Recommendations out of the Fall 2011 CFSAC Meeting

1. This recommendation addresses the process by which CFSAC transmits recommendations to the Secretary and the Secretary communicates back to CFSAC whether or not a recommendation was acted upon. CFSAC recommends that this process be transparent and clearly articulated to include regular feedback on the status of the committee’s recommendations. This communication could originate directly from the Office of the Secretary or be transmitted via the relevant agency or agencies.

2. CFSAC recommends to the Secretary that the NIH or other appropriate agency issue a Request for Applications (RFA) for clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).

3. CFSAC would like to encourage and support the creation of the DHHS Interagency Working Group on Chronic Fatigue Syndrome and ask this group to work together to pool resources that would put into place the “Centers of Excellence” concept that has been recommended repeatedly by this advisory committee. Specifically, CFSAC encourages utilizing HHS agency programs and demonstration projects, available through the various agencies, to develop and coordinate an effort supporting innovative platforms that facilitate evaluation and treatment, research, and public and provider education. These could take the form of appropriately staffed physical locations, or be virtual networks comprising groups of qualified individuals who interact through a variety of electronic media. Outreach and availability to underserved populations, including people who do not have access to expert care, should be a priority in this effort.

4. This multi‐part recommendation pertains to classification of CFS in ICD classification systems:

a) CFSAC considers CFS to be a multi‐system disease and rejects any proposal to classify CFS as a psychiatric condition in the U.S. disease classification systems.

c) CFSAC continues to recommend that CFS should be classified in ICD‐10‐CM in Chapter 6 under Diseases of the Nervous System at G93.3 in line with ICD‐10, the World Health Organization, and ICD‐10‐CA, the Canadian Clinical Modification and in accordance with CFSAC’s recommendations of August 2005 and May 2011. CFSAC rejects CDC’s National Center for Health Statistics Option 2 and recommends that CFS remain in the same code and the same subcode as myalgic encephalomyelitis because CFS includes both viral and non‐viral triggers.

d) CFSAC recommends that an “excludes one” [sic *] be added to G93.3 for chronic fatigue, R53.82, and neurasthenia, F48.8. CFSAC recommends that these changes be made in ICD‐10‐CM prior to its rollout in 2013.

This final recommendation was also provided to the National Center for Statistics at the CDC prior to the November 18, 2011 deadline for comments along with the following rationale:

We feel that the interests of patients, the scientific and medical communities, continuity and logic are best served by keeping CFS, (B)ME (Benign Myalgic Encephalomyelitis) and PVFS (Post Viral Fatigue Syndrome) in the same broad grouping category. Current scientific evidence would indicate there are more similarities between the three entities than there are differences. Whether they are synonyms for the same underlying concept, disease entities and sub‐entities, or merely the best coding guess is unclear. In reality, any or all of the above may be correct. While the relationship between CFS, B(ME) and PVFS is not stated, that they are grouped together in ICD 10 (WHO) would indicate some rationale for a connection. Our understanding is that this association will be maintained in the ICD 11, which may also include further description of the relationship. Exclusions specific to chronic fatigue (a symptom present in many illnesses) and neurasthenia (not a current diagnosis) also seem to be under consideration for ICD 11.

*Ed: Should be “Excludes1”. For definitions for “Excludes1” and “Excludes2” see Post #118

The Minute for Ms Pickett’s presentation “International Classification of Diseases—Clinical Modification (ICD‐CM) Donna Pickett, National Center for Health Statistics (NCHS/Centers for Disease Control and Prevention)” and Committee discussions in response to that presentation can be found on Pages 4-10 of the PDF for Minutes Day One (November 8, 2011).

The Minute for the proposal and unanimous approval of a revised and expanded Recommendation to HHS on the coding of CFS in ICD-10-CM can be found on Pages 43-44 of the PDF for Minutes Day Two (November 9, 2011). Video in Post #118.

As reported in Post #118, following the September 14 meeting of the ICD-9-CM Coordination and Maintenance Committee, NCHS had invited comments from stakeholders on the proposals in Option 1 (presented by the Coalition for ME/CFS) and Option 2 (alternative proposals by NCHS).

The closing date for comments was November 18, 2011.

A decision was expected before the end of December but since any decision that might have been reached on these proposals has yet to be announced, I have raised some queries with Ms Pickett around the decision making process (see Post #118). I will update when a response has been received from Ms Pickett’s office or a public announcement made.